Fibrosis File

Pirfenidone Approval News

Pirfenidone is a drug that has been developed by InterMune, Inc. to treat patients suffering from idiopathic pulmonary fibrosis (IPF). Afflicting up to 200,000 people in the U.S., IPF scars the lungs, causing the tissue to thicken and be less able to move oxygen into the blood.

At the end of 2009, the FDA accepted pirfenidone’s new drug application and gave the company a Prescription Drug User Fee Act (PDUFA) goal date. This is the date on which the FDA must complete its review and let Intermune know whether it has accepted the application or not. Usually, it takes the FDA nine months to review a submission. The FDA gave the application for pirfenidone both Orphan Drug and Fast Track designa- tion and Priority Review designation since the FDA thinks that the drug, if approved, may provide significant progress in the treatment of IPF. The Coalition for Pulmonary Fibrosis (CPF) and the Pulmonary Fibrosis Foundation (PFF) are applauding the efforts of patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treat- ment options. Patient Tommy Spivey traveled with his wife from Wilmington, North Carolina to speak to the panel. “I have one grandchild and one on the way and I would like to live long enough to get to know them,” he said. Spivey, who says his disease is currently not progressing, traveled to Japan in 2009 to gain access to pirfenidone and is currently taking the drug.

On March 9, the Advisory Committee recommended pirfenidone for the treatment of U.S. patients. The FDA will weigh the panel’s recommendation and is expected to make a final decision by May 4, 2010 – the PDUFA date. The Advisory Committee’s recommendations are not binding but will be considered as the FDA completes its review of the New Drug Application. The company wants to  market  the  product  under  the  trade  name  Esbriet®. Applications for use in Europe have also been filed.

Panelists, including those who backed the drug, called for a patient registry to collect more data. “Pirfenidone did not cure IPF,” said Paul Noble, a medical professor at Duke University, “but, it is an important first step in IPF treatment.”image043

If approved, pirfenidone would be the first FDA approved drug for pulmonary fibrosis. The company has been pursuing a treatment for IPF since 2000. Its first candidate was a drug called Actimmune, which proved to be ineffective.